The Myriad Case – DNA as Patentable Subject Matter

Recently, the U.S. Supreme Court issued a unanimous decision in thshutterstock_65757709e case of Association for Molecular Pathology v. Myriad Genetics, Inc., commonly referred to as the Myriad case.   The sole issue before the Supreme Court was whether certain patent claims owned by Myriad Genetics, directed to isolated DNA, were patentable subject matter, and if not, how much manipulation of the isolated DNA was required for the DNA to become patentable subject matter.

The U.S. Supreme Court held that DNA, which is merely isolated from nature, is not patentable subject matter, including mutations existing in nature (such as BRCA1 and BRCA2), because it is simply the isolation of natural DNA away from the surrounding genetic material.  The Court held that regardless of the amount of work involved in identifying these mutations, the mutations already existed in nature.

However, the Court also held that making a complementary DNA (cDNA) caused the newly made cDNA to be eligible for patent protection.  This is an important finding because it provides that a simple manipulation, such as making a cDNA, is sufficient for the claimed subject matter to become patent eligible.  Regarding short cDNA sequences, the Court indicated that if the cDNA sequence was the same as the underlying natural sequence, however, the sequence may no longer be patent eligible.  Finally, the Court made clear what was not covered by the decision, namely, method claims (they were not at issue before the Court), claims to new applications of knowledge from identification of the mutations, and altered sequences.

While many have reported on the result, few reports have provided useful analysis of the impact of the decisions.  First and foremost, lawyers for Myriad have properly and correctly indicated that over 500 other patent claims, which were not at issue in the case, are still valid and enforceable.  Viewed in conjunction with the decision in Mayo Collaborative Services v. Prometheus, Inc., 566 U.S. ___ (2012), it is clear that method claims meeting the standard set in Prometheus and for which sufficient manipulation has occurred are patent eligible.

Regardless of the Myriad decision, Myriad maintains a strong patent position as a result of a systematic and well-planned patent strategy that includes composition of matter, method and system claims.

One key take-home message from the Myriad and Prometheus decisions is the use of continuing applications to maintain at least one case pending as new court decisions implement the new test for patentable subject matter following Myriad and Prometheus.  While not a new strategy, (it is quite common practice with software-related applications) it provides an additional avenue for patent holders to revise claims in on-going prosecution.

Another take-home message from the decision is the increased value of method claims.  The Myriad decision demonstrates the need to use a broad-based claim strategy when filing any patent application, taking advantage of as many claim types as possible, including method claims, method of making claims, system claims, diagnostic method claims, etc.  The Myriad decision also increases the value of method claims over certain types of composition of matter claims.

Finally, while many may be advising clients to conduct extensive reviews of their issued patent portfolios for claims that may no longer be eligible for protection, it makes little sense to conduct an extensive review unless you are about to: (1) license the patent; (2) file suit to enforce the patent; or (3) are about to pay an issue fee or maintenance fee.  For clients with pending patent applications, the opportunity to amend the claims in light of Myriad will arise as the case is examined.  It is highly likely the PTO will issue new examination guidelines as they have in the past when other important decisions changed the patent landscape.